Advanced or Metastatic Solid TumorsPhase 1/2NCT05572684
A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors
A Phase 1/2 study testing NC410 and pembrolizumab in people with Advanced or Metastatic Solid Tumors and Microsatellite Instability Low, run by NextCure, Inc. at 17 sites in United States.
Trial summary
This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors, Microsatellite Instability Low, Microsatellite Instability High
- What is being tested?
- NC410 and pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 17 sitesUnited States
- Study dates
- 6 Oct 2022to 30 Apr 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age on day of signing informed consent.
- Participant with histologically or cytologically confirmed diagnosis of the following advanced unresectable and/or metastatic solid tumors:
- Phase 1b: Participants with solid tumors that are known to be associated as MSS/MSI-low in the majority including: CRC (without liver metastasis), Gastric including GE junction, Esophageal, Ovarian, and H\&N cancer (regardless of prior treatment with ICIs). Note: Participants must have had disease progression after at least one line of systemic standard of care therapy prior to enrollment. Participants who discontinue standard treatment due to intolerance or refuse standard treatment will also be eligible to enroll.
- Phase 2 ICI Refractory Solid Tumors (Cohort 1): Participants with solid tumors including CRC, Gastric including GE junction, Esophageal, Endometrial, H\&N, Lung, Cervical and Ovarian cancer.Participants must have progressed on treatment with an anti-PD1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria:
- Has received at least 2 doses of an approved anti-PD-1/L1 mAb.
- Has demonstrated disease progression after PD-1/L1 as defined by RECIST v1.1.
Show all 16Show fewer
- Phase 2 ICI naïve Solid Tumors (Cohorts 2a-2c):Tumors known to be associated with MSS/MSI-low status such as CRC, Gastric including GE junction, and Ovarian cancer where participants have not been previously treated with ICIs. Note: Participants must have had disease progression after at least one line of systemic standard of care therapy prior to enrollment. Participants who discontinue standard treatment due to intolerance or refuse standard treatment will also be eligible to enroll. Note: Confirmation of MSS/MSI status should be assessed prior to study entry (either by historical result or during screening).
- A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child, from Screening through the treatment period and for at least 120 days after the last dose of study treatment.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP)
- A WOCBP who agrees to follow contraceptive guidance outlined in the protocol from Screening through the treatment period and for at least 120 days after the last dose of study treatment.
- Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Able to provide tumor tissue sample at Screening, archival (≤ 5 years old) or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy greater than or equal to 12 weeks as judged by the Investigator.
- Have adequate organ function as defined in the protocol.
Who cannot join
- A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE.
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to treatment. Note: Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤ 2 requiring treatment or hormone replacement may be eligible. If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention.
- Has received prior radiotherapy within 2 weeks of start of study treatment or has had a history of radiation pneumonitis. Note: Participants must have recovered from all radiation-related toxicities and do not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
- Has received G-CSF or GM-CSF within 7 days prior to start of study treatment.
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
Show all 20Show fewer
- Receipt of COVID-19 vaccine within ≤ 14 days prior to first administration of study treatments. For 2-dose COVID-19 vaccines or COVID-19 booster, participants must wait at least 14-days after administration prior to beginning study treatment.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Has had an allogeneic tissue/stem cell/solid organ transplant.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of bladder, that have undergone potentially curative therapy are not excluded.
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- Has severe hypersensitivity (≥ Grade 3), known allergy or reaction to Pembrolizumab, NC410, and/or any of their excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a known active or history of HIV infection. No HIV testing is required unless mandated by local health authority.
- Has known active Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
University of Cincinnati Cancer Center
Cincinnati, Ohio, 45267
UT Southwestern Medical Center
Dallas, Texas, 75235
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
St. Elizabeth Edgewood Hospital
Edgewood, Kentucky, 41017
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Virginia Cancer Specialist
Fairfax, Virginia, 22031
Hackensack Meridian Health University Medical Center- John Theurer Cancer Center
Hackensack, New Jersey, 07601
MD Anderson Cancer Center
Houston, Texas, 77030
Ochsner Cancer Institute
New Orleans, Louisiana, 70121
NYU Langone Health
New York, New York, 10016
UT Health San Antonio
San Antonio, Texas, 78229
Texas Oncology - San Antonio
San Antonio, Texas, 78240
Arizona Oncology Associates
Tucson, Arizona, 85711
Northwest Cancer Specialist
Vancouver, Washington, 98684
About this study
Official title: A Phase 1b/2, Open-Label, Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab for Participants With Advanced Unresectable and/or Metastatic Immune Checkpoint Inhibitor (ICI) Refractory Solid Tumors or ICI Naïve MSS/MSI-Low Solid Tumors
This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors
- Conditions
- Advanced or Metastatic Solid Tumors, Microsatellite Instability Low, Microsatellite Instability High, Microsatellite Stable, Ovarian Cancer, Gastric Cancer
- Being tested
- NC410, pembrolizumab
- Keywords
- Advanced Cancer, Metastatic Cancer, NC410, Solid Tumors, Immunotherapy, PK, Ovarian Cancer, Gastric Cancer, Colo-rectal Cancer, Esophageal Cancer, Endometrial Cancer, Head Neck Cancer, Immune Checkpoint Inhibitor Refractory, Immune Checkpoint Inhibitor Naïve, Microsatellite Instability Low, Microsatellite Instability High, Microsatellite Stable, Cervical Cancer, Lung Cancer
- Medical subject headings
- Ovarian Neoplasms, Stomach Neoplasms, Colonic Neoplasms, Esophageal Neoplasms, Endometrial Neoplasms, Head and Neck Neoplasms, Uterine Cervical Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NC410Drug
NC410 will be given intravenously (IV) every 2 weeks
pembrolizumabDrug
Also called KEYTRUDA®
Pembrolizumab 400mg will be given IV every 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NC410 and pembrolizumab | Experimental | All participants will receive NC410 (IV) and pembrolizumab (IV) according to the treatment schedule until a reason for treatment discontinuation is reached. Receives: Drug: NC410; Drug: pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
Number of Participants With Treatment-emergent Adverse Events
Measured: From enrollment through up to 90 days after end of treatment, an average of 1 year
Secondary outcomes (8)
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To assess antitumor activity/efficacy by evaluating objective response rate (ORR), defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: until disease progression, up to 24 months
Duration of Response Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To assess antitumor activity/efficacy by evaluating duration of response (DoR), defined as the time from the first documented complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 to the first documented progressive disease or death due to any cause, whichever occurs first. Subjects who are alive and progression free as of the analysis cut-off date, who discontinued the treatment or switched to a new treatment will be censored at their last evaluable tumor response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: CompleteResponse (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions
Measured: until disease progression or death, up to 24 months
Disease Control Rate Per RECIST v1.1
To assess antitumor activity/efficacy by evaluating disease control rate (DCR), defined as the proportion of participants in whom a documented complete response, partial response, or stable disease is observed as the best overall response (lasting 24weeks or longer) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: until disease progression, up to 24 months
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To evaluate progression-free survival (PFS), defined as time (in months) from starting study treatment to the first documented progressive disease or death due to any cause, whichever occurs first. Progressive disease will include both 'Progressive Disease' and 'Clinical Signs and Symptoms Consistent with Progressive Disease' from the RECIST CRFs. For participants who are alive and progression free at the time of discontinuation from study, data cutoff for analysis, or use of other anticancer drug, PFS will be censored at the last tumor assessment date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: until disease progression, up to 24 months
Overall Survival (OS)
Overall Survival, estimated using Kaplan-Meier, is defined as time in months from start of study treatment to death due to any cause. Subjects who were alive at the time of discontinuation from study or data cutoff for analysis were censored at their last known alive (LKA) date.
Measured: From start of study treatment until death due to any cause or censoring at the last known alive date, assessed up to 24 months.
Maximum Serum Concentration (Cmax) of NC410
Maximum observed NC410 serum concentration at Cycle 1. Note participants enrolled at 200mg dose level were dosed with 100mg of NC410 at Cycle 1 Day 1.
Measured: PK samples collected pre-dose, 30 minutes post-NC410 infusion (end of infusion) on Day 1, 24 hours post-infusion on Day 2, at any time on Day 8 and pre-dose sample on Day 15
Terminal Elimination Half-life (t1/2) of NC410
Terminal elimination half-life, in hours, calculated as 0.693/λz after each dose administration at Cycle 1. Note partipants enrolled at 200mg dose level were dosed with 100mg of NC410 at Cycle 1 Day 1.
Measured: PK samples collected pre-dose, 30 minutes post-NC410 infusion (end of infusion) on Day 1, 24 hours post-infusion on Day 2, at any time on Day 8 and pre-dose sample on Day 15
Area Under the Serum Concentration Versus Time Curve (AUC) of NC410
Area under the curve from the time of dosing to the time of the last measurable concentration at Cycle 1 Day 1.
Measured: Time of dosing to the time of the last measurable PK concentration at Cycle 1 Day 1. Samples taken pre-dose and 30-min post dose at Cycle 1 Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start6 Oct 2022
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Why it stopped: Following completion of Phase 1b, the Sponsor decided not to initiate Part 2 of the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- NextCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Udayan Guha, MD, Study director, NextCure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572684
- Sponsor's protocol ID
- NC410-02
- Other IDs
- MK-3475-D88, KEYNOTE-D88
- Status last verified
- Jul 2026
- First submitted
- 5 Oct 2022
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Open-Label, Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab for Participants With Advanced Unresectable and/or Metastatic Immune Checkpoint Inhibitor (ICI) Refractory Solid Tumors or ICI Naïve MSS/MSI-Low Solid Tumors
- ClinicalTrials.gov ID
- NCT05572684
- Acronym / sponsor ID
- NC410-02
- Conditions
- Advanced or Metastatic Solid Tumors, Microsatellite Instability Low, Microsatellite Instability High, Microsatellite Stable, Ovarian Cancer, Gastric Cancer
- Keywords
- Advanced Cancer, Metastatic Cancer, NC410, Solid Tumors, Immunotherapy, PK, Ovarian Cancer, Gastric Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following completion of Phase 1b, the Sponsor decided not to initiate Part 2 of the trial.
- Enrolment
- 97 participants (actual)
- Lead sponsor
- NextCure, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NC410 and pembrolizumab | Experimental | Drug: NC410, Drug: pembrolizumabAll participants will receive NC410 (IV) and pembrolizumab (IV) according to the treatment schedule until a reason for treatment discontinuation is reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Be 18 years of age on day of signing informed consent.
- Participant with histologically or cytologically confirmed diagnosis of the following advanced unresectable and/or metastatic solid tumors:
- A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child, from Screening through the treatment period and for at least 120 days after the last dose of study treatment.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Key exclusion criteria (20 listed)
- A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE.
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to treatment. Note: Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤ 2 requiring treatment or hormone replacement may be eligible. If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention.
- Has received prior radiotherapy within 2 weeks of start of study treatment or has had a history of radiation pneumonitis. Note: Participants must have recovered from all radiation-related toxicities and do not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
- Has received G-CSF or GM-CSF within 7 days prior to start of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NC410NC410 will be given intravenously (IV) every 2 weeks | Drug | NC410 and pembrolizumab |
| pembrolizumabAlso: KEYTRUDA®Pembrolizumab 400mg will be given IV every 6 weeks. | Drug | NC410 and pembrolizumab |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
Time frame: From enrollment through up to 90 days after end of treatment, an average of 1 year
Number of Participants With Treatment-emergent Adverse Events
8 secondary outcomes
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: until disease progression, up to 24 months
Duration of Response Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: until disease progression or death, up to 24 months
Disease Control Rate Per RECIST v1.1
Time frame: until disease progression, up to 24 months
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: until disease progression, up to 24 months
Overall Survival (OS)
Time frame: From start of study treatment until death due to any cause or censoring at the last known alive date, assessed up to 24 months.
Maximum Serum Concentration (Cmax) of NC410
Time frame: PK samples collected pre-dose, 30 minutes post-NC410 infusion (end of infusion) on Day 1, 24 hours post-infusion on Day 2, at any time on Day 8 and pre-dose sample on Day 15
Terminal Elimination Half-life (t1/2) of NC410
Time frame: PK samples collected pre-dose, 30 minutes post-NC410 infusion (end of infusion) on Day 1, 24 hours post-infusion on Day 2, at any time on Day 8 and pre-dose sample on Day 15
Area Under the Serum Concentration Versus Time Curve (AUC) of NC410
Time frame: Time of dosing to the time of the last measurable PK concentration at Cycle 1 Day 1. Samples taken pre-dose and 30-min post dose at Cycle 1 Day 1.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Advanced or Metastatic Solid Tumors
RecruitingEarly Phase 1
mRNA Vaccine for Advanced Lung Cancer and Pulmonary Metastases of Solid Tumors
Advanced Lung Cancer, Lung Metastasis
Not yet recruitingPhase 1
An Investigational Study of BON-106 in Adults With Advanced or Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
RecruitingPhase 1/2
A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors
Locally Advanced or Metastatic Solid Tumors
RecruitingPhase 2
Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
MSI-H/dMMR Solid Tumors
Not yet recruitingPhase 1
A Study to Evaluate YF550 in Participants With Locally Advanced or Metastatic Solid Tumors.
Solid Tumor (Phase I), Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Udayan Guha, MD study director
NextCure, Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NC410 and pembrolizumab in people with Advanced or Metastatic Solid Tumors and Microsatellite Instability Low, run by NextCure, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 (time frame: From enrollment through up to 90 days after end of treatment, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.